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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST SENSURA XPRO CONVEX 1 PC DRAINABLE OSTOMY POUCH

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COLOPLAST SENSURA XPRO CONVEX 1 PC DRAINABLE OSTOMY POUCH Back to Search Results
Model Number 15695
Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Anxiety (2328); Depression (2361)
Event Date 01/01/2010
Event Type  Injury  
Event Description
Ongoing issues with product defects resulting in repeated fecal failures from the coloplast sensura xpro convex ostomy pouch. This has been a 7 year battle with product quality decidedly degraded since 2013. I have photos of issues which go beyond application and fit. The product sadly is the best fit of these in the marketplace i have found since my last surgery in 2007. The issues cost me a career and exacerbated my depression along with developing panic and anxiety attacks. My 2013 the failures were so bad i was advised by a medical professional to file for disability because of all the jobs i had lost due to feces draining on me at any given time. In front of clients, during job interviews, in my car on the expressway, in my bed, ss approved my claim immediately, but even then i lost everything, my career, my vehicle, my home and furnishings. I still have no credit score. From the corporate double speak they are hiding the fact of poor quality in mfg. They have changed over the cheaper materials. Now that so many people have expanded into medicaid, they can sell more products and make it cheaper. They have also increased product offerings to offset the lower quality of the pouches. Lifting at the edge of the barrier became a problem in the past 2 years and rather than use a quality adhesive material that worked in the past. They now sell an extra product to correct the lift. Medicare and medicaid get billed (b)(6) per month. I get because of the human body failures can happen. I have dealt with way above the average because of poorly made stoma by the surgeon. That is bad enough, but my logs and photos show the decline in product quality with the expansion of insurance coverage. I truly think there is a deliberate coverup and fraud. The more failures the more people need to apply a new pouch, so the more they need to buy. I did consult a stoma clinic and they told me i was skilled with applying the pouch and using the skin barrier patches i hand trimmed to give me the optimum protection. Meaning i knew what i was doing and was using the best mix for my body.
 
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Brand NameSENSURA XPRO CONVEX 1 PC DRAINABLE OSTOMY POUCH
Type of DeviceOSTOMY POUCH
Manufacturer (Section D)
COLOPLAST
MDR Report Key7049085
MDR Text Key92765344
Report NumberMW5073468
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15695
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2017 Patient Sequence Number: 1
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